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Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria

Primary Purpose

Erythropoietic Protoporphyria

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
cysteine hydrochloride
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythropoietic Protoporphyria focused on measuring erythropoietic protoporphyria, inborn errors of metabolism, porphyria, rare disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL --Prior/Concurrent Therapy-- At least 3 months since prior betacarotene or L-cysteine No concurrent betacarotene --Patient Characteristics-- Fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter Not pregnant or nursing

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004940
    Brief Title
    Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1996 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2001 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Determine the long-term efficacy and safety of L-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.
    Detailed Description
    PROTOCOL OUTLINE: This is a phase III study, lasting 3 years; 1996-1999. Patients are administered L-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch. Patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erythropoietic Protoporphyria
    Keywords
    erythropoietic protoporphyria, inborn errors of metabolism, porphyria, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cysteine hydrochloride

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Erythropoietic protoporphyria RBC protoporphyrin greater than 50 micrograms/100 dL --Prior/Concurrent Therapy-- At least 3 months since prior betacarotene or L-cysteine No concurrent betacarotene --Patient Characteristics-- Fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter Not pregnant or nursing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Micheline Mary Mathews-Roth
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase III Study of L-Cysteine in Patients With Erythropoietic Protoporphyria

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